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HRP20191966T4 - Stabilizirani neproteinski klostridijalni pripravci toksina - Google Patents

Stabilizirani neproteinski klostridijalni pripravci toksina Download PDF

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Publication number
HRP20191966T4
HRP20191966T4 HRP20191966TT HRP20191966T HRP20191966T4 HR P20191966 T4 HRP20191966 T4 HR P20191966T4 HR P20191966T T HRP20191966T T HR P20191966TT HR P20191966 T HRP20191966 T HR P20191966T HR P20191966 T4 HRP20191966 T4 HR P20191966T4
Authority
HR
Croatia
Prior art keywords
pharmaceutical preparation
liquid pharmaceutical
poloxamer
trehalose
methionine
Prior art date
Application number
HRP20191966TT
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English (en)
Inventor
Maurice Abiad
Bhas Dani
Evgenyi Shalaev
Original Assignee
Allergan, Inc.
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=59974865&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20191966(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Allergan, Inc. filed Critical Allergan, Inc.
Publication of HRP20191966T1 publication Critical patent/HRP20191966T1/hr
Publication of HRP20191966T4 publication Critical patent/HRP20191966T4/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • A—HUMAN NECESSITIES
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893—Botulinum neurotoxin (3.4.24.69)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
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    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/24—Metalloendopeptidases (3.4.24)
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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  • Health & Medical Sciences (AREA)
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  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
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Claims (7)

1. Postupak proizvodnje tekućeg farmaceutskog pripravka bez procesa liofilizacije, pri čemu tekući farmaceutski pripravak sadrži: (i) botulin toksin; (ii) poloksamer 188; (iii) metionin; i (iv) trehalozu pri čemu pripravak sadrži pufer, pri čemu je pufer histidin, pri čemu je pH vrijednost u rasponu 5-7, pri čemu su količine relativne težine (%, w/w) trehaloze, poloksamera 188, metionina unutar sljedećih raspona: trehaloza 1 do 10 poloksamer 188 0.5 do 5 metionin 0.1 do 0.3
2. Postupak proizvodnje tekućeg farmaceutskog pripravka u skladu s patentnim zahtjevom 1, pri čemu tekući farmaceutski pripravak nadalje sadrži NaCl i/ili EDTA, pri čemu količine relativne težine (%, w/w) NaCl i EDTA su opcionalno unutar sljedećih raspona: NaCl 0.1 do 10 i/ili EDTA 0.01 do 0.1.
3. Postupak proizvodnje tekućeg farmaceutskog pripravka u skladu s patentnim zahtjevom 1, pri čemu količine relativne težine (%, w/w) trehaloze, poloksamera 188, metionina, i opcionalno NaCl, i opcionalno EDTA u tekućem farmaceutskom pripravku su: a) trehaloza 7 do 9 poloksamer 188 3.5 do 4.5 metionin 0.15 do 0.25; i poželjno su trehaloza 8 poloksamer 188 4 metionin 0.2; ili b) trehaloza 7 do 9 poloksamer 188 0.5 do 0.7 metionin 0.15 do 0.25; i poželjno su trehaloza 8 poloksamer 188 0.6 metionin 0.2; ili c) trehaloza 1 do 3 poloksamer 188 3.5 do 4.5 metionin 0.15 do 0.25 NaCl 0.4 do 0.8; i poželjno su trehaloza 2 poloksamer 188 4 metionin 0.2 NaCl 0.6; ili d) trehaloza 7 do 9 poloksamer 188 3.5 do 4.5 metionin 0.15 do 0.25 EDTA 0.01 do 0.05; i poželjno su trehaloza 8 poloksamer 188 4 metionin 0.2 EDTA 0.03.
4. Postupak proizvodnje tekućeg farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva od 1 - 3, pri čemu u tekućem farmaceutskom pripravku koncentracija histidina je 20 mM, i pri čemu je u tekućem farmaceutskom pripravku pH poželjno u rasponu 5.5 – 6.
5. Postupak proizvodnje tekućeg farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva od 1 do 4, pri čemu se tekući farmaceutski pripravak sastoji od jednog ili više botulin toksina, trehaloze, poloksamera 188, metionina, pufera pri čemu je pufer histidin, i opcionalno NaCl, i opcionalno EDTA.
6. Postupak proizvodnje tekućeg farmaceutskog pripravka u skladu s bilo kojim od prethodnih patentnih zahtjeva, pri čemu tekući farmaceutski pripravak ne sadrži protein životinjskog porijekla.
7. Postupak proizvodnje tekućeg farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva od 1 do 6, pri čemu tekući farmaceutski pripravak sadrži natrijevu sol etilen diamin tetraoctene kiseline (EDTA) ili EDTA analog, pri čemu je količina relativne težine (%, w/w) EDTA opcionalno raspona od otprilike 0.01 do 0.10.
HRP20191966TT 2016-09-13 2017-09-13 Stabilizirani neproteinski klostridijalni pripravci toksina HRP20191966T4 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662394009P 2016-09-13 2016-09-13
EP17784058.4A EP3436054B2 (en) 2016-09-13 2017-09-13 Stabilized non-protein clostridial toxin compositions
PCT/US2017/051369 WO2018053004A2 (en) 2016-09-13 2017-09-13 Non-protein clostridial toxin compositions

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HRP20191966T1 HRP20191966T1 (hr) 2020-01-24
HRP20191966T4 true HRP20191966T4 (hr) 2022-09-16

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HRP20191966TT HRP20191966T4 (hr) 2016-09-13 2017-09-13 Stabilizirani neproteinski klostridijalni pripravci toksina

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US (9) US10369190B2 (hr)
EP (4) EP3626259A1 (hr)
JP (3) JP7217700B2 (hr)
KR (5) KR102635959B1 (hr)
CN (3) CN109803672A (hr)
AU (3) AU2017327369A1 (hr)
BR (2) BR112019004935A2 (hr)
CA (2) CA3036095A1 (hr)
CL (1) CL2019000586A1 (hr)
CO (1) CO2019003630A2 (hr)
CY (2) CY1122263T1 (hr)
DK (2) DK3436054T4 (hr)
ES (2) ES2755815T3 (hr)
HR (1) HRP20191966T4 (hr)
HU (2) HUE046290T2 (hr)
IL (2) IL308091A (hr)
LT (1) LT3436054T (hr)
MX (2) MX2019002835A (hr)
PH (1) PH12019500501A1 (hr)
PL (2) PL3436054T5 (hr)
PT (2) PT3436054T (hr)
RS (1) RS59600B2 (hr)
RU (2) RU2019110875A (hr)
SA (1) SA519401298B1 (hr)
SI (2) SI3436054T2 (hr)
TW (2) TW202247855A (hr)
WO (2) WO2018053004A2 (hr)

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